February 24, 2014
Pfizer Inc. today announced that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects evaluating the efficacy of Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 65 years of age and older, achieved its primary clinical objective and both secondary clinical objectives. CAPiTA is the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults.
The primary objective of the study was to demonstrate efficacy of Prevenar 13 against a first episode of vaccine-type community-acquired pneumonia (CAP). The CAPiTA study also met both secondary objectives, which were efficacy against a first episode of non-bacteremic/non-invasive vaccine-type CAP and a first episode of vaccine-type invasive pneumococcal disease (IPD).
Vaccine-type CAP (VT-CAP) was defined as CAP caused by any S. pneumoniae serotype included in the vaccine. Non-bacteremic/non-invasive VT-CAP was defined as CAP in which vaccine-type S. pneumoniae caused the pneumonia, but was not detected concurrently in the bloodstream or any other normally sterile site. Vaccine-type IPD was defined as a case in which vaccine-type S. pneumoniae was present in the bloodstream or any other normally sterile site, with or without pneumonia.
“We are pleased with the outcome of the CAPiTA study, which demonstrated that Prevenar 13 can prevent vaccine-type pneumococcal community-acquired pneumonia in adults,” said Dr. William Gruber, senior vice president, Vaccine Clinical Research, Pfizer.
“Pneumococcal pneumonia is a significant cause of illness and death in adults around the world, and the potential to reduce the burden of this disease through direct vaccination of adults represents a meaningful public health benefit,” said Dr. Emilio A. Emini, senior vice president, Vaccine Research and Development, Pfizer. “Pfizer looks forward to sharing the CAPiTA data with U.S. and worldwide regulatory authorities, and vaccine technical committees, to help inform decisions regarding potential Prevenar 13 label and recommendation updates.”
The CAPiTA data will be an important component in any consideration of potential new or updated Prevenar 13 recommendations for adults. In addition, other key factors will be taken into consideration, such as the current burden of pneumococcal disease in adults.
Prevnar 13 was licensed by the FDA under an accelerated approval process to address an unmet medical need in older adults. As a requirement of the accelerated approval pathway, Pfizer conducted CAPiTA to verify clinical benefit.
Detailed results will be presented at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March 12, 2014, during the late-breaker session from 2:30 p.m. to 4:10 p.m. IST/5 a.m. to 6:40 a.m. EDT.
About Pneumococcal Disease
Pneumococcal disease refers to a group of illnesses caused by S. pneumoniae bacteria. Invasive pneumococcal disease occurs when bacteria enter the bloodstream, or another site that is normally sterile. Non-invasive pneumococcal pneumonia occurs when the bacteria cause infection in the lungs but are not detected in the blood concurrently.1 In adults, pneumonia is the most common presentation of pneumococcal disease.1 For every one case of invasive pneumococcal pneumonia in adults, it is estimated that at least three cases of non-invasive pneumococcal pneumonia occur. While non-invasive forms of pneumococcal disease are typically more common, the invasive types of disease are generally more severe.
As part of its regulatory commitments under the FDA’s accelerated approval program, Pfizer conducted the CAPiTA study, which was designed to evaluate the efficacy of Prevnar 13 in the prevention of vaccine-type pneumococcal pneumonia. CAPiTA is the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults. It involved approximately 85,000 subjects aged 65 years and older. The trial was conducted by Julius Clinical, a spin-off of the Julius Center for Health Sciences and Primary Care, a division of the University Medical Center Utrecht in the Netherlands. Fifty-eight sentinel hospitals were used for the surveillance of CAP and IPD. The safety profile of Prevenar 13 observed in CAPiTA was consistent with studies previously conducted in adults. The safety data will be included in the presentation at ISPPD.
About Prevenar 13
Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the United States and Japan. It is the most widely used pneumococcal conjugate vaccine (PCV) in the world, and more than 640 million doses of Prevenar 7-valent/Prevenar 13 have been distributed worldwide. In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 90 countries, and is also approved in the United States and European Union (EU) for use in older children and adolescents aged 6 to 17 years. Recently, Prevenar 13 was also approved in the EU for use in adults 18 to 49 years of a
Find the original press release here.